Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 6.25MG BASE | 1 | AXERT | ALMOTRIPTAN MALATE |
| 002 | TABLET;ORAL | EQ 12.5MG BASE | 1 | AXERT | ALMOTRIPTAN MALATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2001-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2004-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2009-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2009-03-27 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2009-04-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2009-04-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 2014-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2017-05-15 | STANDARD |
| UNKNOWN; | SUPPL | 18 | AP | 2009-01-13 | UNKNOWN |
Submissions Property Types
| SUPPL | 11 | Null | 26 |
| SUPPL | 14 | Null | 31 |
| SUPPL | 15 | Null | 6 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 21001
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"AXERT","activeIngredients":"ALMOTRIPTAN MALATE","strength":"EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"AXERT","activeIngredients":"ALMOTRIPTAN MALATE","strength":"EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/15\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021001s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021001s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2009","submission":"SUPPL-11","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021001s010s011lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2009","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021001s010s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2009","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021001s008s009lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2009","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021001s008s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21001_Axert_prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AXERT","submission":"ALMOTRIPTAN MALATE","actionType":"EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"AXERT","submission":"ALMOTRIPTAN MALATE","actionType":"EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-05-15
)
)